IRB Reviewer’s Worksheet - Research Affairs



LLUH IRB Primary Reviewer’s Worksheet

New Applications

I. Present to the IRB your overview of the proposal; document below the areas of specific concern or discussion:

A. Rationale

B. Objectives/Problem Statement

C. Background studies

D. Methods

E. Experimental or approved procedures/drugs/devices

F. Required for standard care vs. required only for purpose of study

G. Comment on investigator's response to IRB Application Item X: Are all study procedures from the protocol listed? Are assumptions as to what is standard of care reasonable from your clinical experience?

H. If a placebo is involved, is it ethically acceptable?

I. What is your conclusion as to whether the study design is likely to accomplish objectives.

II. Identify the study population(s)

A. Is there adequate rationale/justification to using special (vulnerable) populations (children, pregnant women, fetus, prisoners, mentally ill, economically or educationally disadvantaged persons)?

B. Are protections for such populations adequate or appropriate, including parental or surrogate permission?

C. Do recruitment procedures ensure voluntary participation?

D. Describe any features of recruitment that raise concerns regarding equitable representation or coercion.

E. If incentives and/or cost reimbursement is offered, are they either unfair nor unduly coercive?

III. Do the benefits outweigh the risks?

A. Direct the IRB's attention to the protocol's description of risks, noting those that are specifically related to study participation rather than standard care. Comment whether such risks are reasonable.

B. Will the subject benefit individually or as a population (or both)?

C. Has due care been used to minimize risks and maximize the likelihood of benefits?

D. Are there adequate provisions for reassessing the risks and benefits (i.e., should there be a data and safety monitoring committee)?

E. If study population involves minors, complete the Risk Determination section below.

IV. Consent Document/Process

A. Comprehensive (contains all elements of consent: attach completed consent checklist)

B. Accurate/complete (consistent with protocol)

C. Understandable (use of lay language appropriate for 8th grade level)

D. Consent process: With reference to the applicant's responses to section VII-E of the IRB application regarding subject recruiting, comment on the following:

1. Is there enough time for questions and answers and for considering alternatives before making a decision?

2. Who should the IRB approve to conduct the consent? Are all investigators listed on the application qualified to conduct the consent?

V Other points of concern for IRB discussion

VI. What is your conclusion as to whether the study benefits outweigh risks?

VIII. Motion (Provide wording below, including conditions of approval and risk assignment):

Determination of risk in studies involving minors

Select the FDA and OHRP category that best fits this study. If your motion is to approve or conditionally approve the study, include a reference to the selected text in your motion.

Not involving greater than minimal risk [21 CFR 50.51, 45 CFR 46.404]

Involving greater than minimal risk-prospect of direct benefit to individual subjects [21 CFR 50.52, 45 CFR 46.405]

Involving greater than minimal risk-no prospect of direct benefit to individual subjects-likely to yield generalizable knowledge about the subject's disorder or condition [21 CFR 50.53, 45 CFR 46.406]

Not otherwise approvable- opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children [21 CFR 50.54, 45 CFR 46.407]

For further information, see:

• R. Amdur, Institutional Review Board Member Handbook, chapter “Research involving children.”

• Office of Human Research Protections Special Protections for Children as Research Subjects:

• U.S. Food and Drug Administration 21 CFR 50 – Subpart D Additional Safeguards for Children in Clinical Investigations:

For studies involving Pregnant Women, Fetuses and Neonates

See Worksheet for IRB Determination Appendix B

Submit this, together with your copy of the protocol (marked with your annotations) to the IRB secretary (see box marked "Reviewers Packages") before leaving the room.

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IRB#____________

PI:_______________

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